Actually, the drug already received "fast Track" status, now they are seeking priority review. Much of the material was submitted prior to seeking the NDA through the "rolling review" process. 80 % of companies seeking priority review get it, if previously fast tracked. Perfect world, maybe June..It's odd, we've discussed this drug for so long I beleive some may be jaded to the concept of finally being approved. Well, wake up folks, the time is nigh!!..For those waiting, time to start rounding up those scattered ducks...........;^)
very soon, early January, the FDA will announce whether or not Telaprevir gets fast track application for approval. If Vertex is successful, then it will be 6 months for final approval (or not.) It has taken Vertex 15 years to get this point. Those of us needing treatment and whose type of Hec C this med works for, should be very pleased and hopeful, as am I.
wait for telaprevir coming out next year.
Hi Tehmina,
Sorry to hear of your mother’s dilemma; unfortunately, viral relapse occurs in roughly half of genotype 1 patients.
The decision to undergo therapy is best driven by the patient’s degree of scarring, or fibrosis that they’ve sustained over the course of their disease. Has your mother had a liver biopsy to assess fibrosis? If so, what was the numerical stage of damage?
If she currently has little liver damage, a case could be made to postpone therapy in favor of more effective treatments such as Telaprevir/Boceprevir. Vertex Pharmaceutical formally applied to the U.S. FDA last month; they’ll hopefully receive approval sometime in 2011.
Infergen/Consensus interferon is a possibility; although her odds of success are thought to be less than 32%, assuming her fibrosis is F1-F3: [Thanks Trish…]
“Patients achieving the greatest reduction in baseline viral load with peg-IFN/RBV therapy, especially in patients demonstrating > 1-log drop with initial therapy
Patients with fibrosis scores of F0 to F3 at baseline demonstrated SVRs of 7.8% in the 9 mcg arm and 13.1% in the 15 mcg arm
Patients maintaining full dose of INFERGEN/RBV therapy had SVRs of 7% and 17% for the 9 mcg and 15 mcg arms respectively
Patients demonstrating partial response (>2-log drop) with previous treatment and low fibrosis scores F0-F3 had SVRs of 10.7% and 31.6% for the 9 mcg and 15 mcg arms”
http://www.ncbi.nlm.nih.gov/pubmed/19291790?dopt=Abstract
Good luck to you and your mother—
--Bill